K-number	K010814
Device name	EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
Applicant	Syva Co., Dade Behring, Inc.
Product code	KLT
Device class	Class II
Decision date	Apr 13, 2001
Decision	Substantially Equivalent
Regulation	862.3645

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EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

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